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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03540433




Registration number
NCT03540433
Ethics application status
Date submitted
17/05/2018
Date registered
30/05/2018
Date last updated
4/02/2025

Titles & IDs
Public title
International Observational Study on Perioperative Cognitive Trajectories (POCD Census International/PCI)
Scientific title
Evaluation of POCD-Census Prospective, International Observation Study
Secondary ID [1] 0 0
PCI
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Cognitive Deficit (POCD) 0 0
Neurocognitive Disorders 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Learning disabilities
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Study group - Surgical patients aged =70 years

Control group - Healthy subjects, aged =70 years, American Society of Anesthesiologists (ASA) I+II+III, no surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of postoperative cognitive dysfunction (POCD)
Assessment method [1] 0 0
Neuropsychological testing
Timepoint [1] 0 0
Up to 1 year
Secondary outcome [1] 0 0
Incidence of postoperative cognitive dysfunction (POCD)
Assessment method [1] 0 0
Neuropsychological testing
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Positive cognitive screening
Assessment method [2] 0 0
Short neuropsychological testing
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Mild Neurocognitive Disorder
Assessment method [3] 0 0
Definition according to DSM-V as proposed in Evered L et al. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery. Br J Anaesth, Anesthesiology, Can J Anesth, Anesth Analg, J Alz Dis, acta scandinavica anaesthesiologica (Joint Publication) 2017; Accepted, In Press. We will use an I-pad based neuropsychological test battery (CANTAB connect), and cognitive screening instruments (MOCA, Mini-Cog™ and Animal naming test on verbal fluency from ACE-R) for assessment of cognitive function, MMQ and IQ-code for self- or by proxy reported cognitive concern and ADL/IADL for assessment of functional status. Mild/major Neurocognitive Disorder measured at baseline (pre-existing NCD) 3 months and 1 year (with specifier 'POCD'), 2- and 5 years after surgery
Timepoint [3] 0 0
Up to five years
Secondary outcome [4] 0 0
Major Neurocognitive Disorder
Assessment method [4] 0 0
Definition according to DSM-V as proposed in Evered L et al. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery. Br J Anaesth, Anesthesiology, Can J Anesth, Anesth Analg, J Alz Dis, acta scandinavica anaesthesiologica (Joint Publication) 2017; Accepted, In Press. We will use an I-pad based neuropsychological test battery (CANTAB connect), and cognitive screening instruments (MOCA, Mini-Cog™ and Animal naming test on verbal fluency from ACE-R) for assessment of cognitive function, MMQ and IQ-code for self- or by proxy reported cognitive concern and ADL/IADL for assessment of functional status. Mild/major Neurocognitive Disorder measured at baseline (pre-existing NCD) 3 months and 1 year (with specifier 'POCD'), 2- and 5 years after surgery
Timepoint [4] 0 0
Up to five years
Secondary outcome [5] 0 0
Cerobrospinal fluid biomarker for diagnosing dementia
Assessment method [5] 0 0
Patients for spinal anesthesia who consented on lumbar puncture receive biomarkers analysis from spinal fluid (beta Amyloid 1-40, beta-Amyloid 1-42, beta-Amyloid Ratio (42/40\*10), phospho-TAU, Protein 14-3-3, PRPSc, TAU (Gesamt-Tau)).
Timepoint [5] 0 0
Up to five years
Secondary outcome [6] 0 0
Blood biomarker for diagnosing dementia
Assessment method [6] 0 0
Patients consented on blood sampling receive biomarker analysis from blood (Apolipoprotein E).
Timepoint [6] 0 0
Up to five years
Secondary outcome [7] 0 0
Findings of memory consultation session
Assessment method [7] 0 0
Timepoint [7] 0 0
Up to five years
Secondary outcome [8] 0 0
Comorbidities
Assessment method [8] 0 0
Comorbidities will be quantified by use of Charlson Comorbidity index
Timepoint [8] 0 0
Up to five years
Secondary outcome [9] 0 0
Nutritional status
Assessment method [9] 0 0
Changes in the nutritional status after elective surgery are measured by a questionnaire.
Timepoint [9] 0 0
Up to five years
Secondary outcome [10] 0 0
Malnutrition 1
Assessment method [10] 0 0
Malnutrition is measured by the Body mass index
Timepoint [10] 0 0
Up to five years
Secondary outcome [11] 0 0
Malnutrition 2
Assessment method [11] 0 0
Malnutrition is measured by weight
Timepoint [11] 0 0
Up to five years
Secondary outcome [12] 0 0
Malnutrition 3
Assessment method [12] 0 0
Malnutrition is measured by weight
Timepoint [12] 0 0
Up to five years
Secondary outcome [13] 0 0
Dental health
Assessment method [13] 0 0
The dental status is determined by tooth doctors
Timepoint [13] 0 0
Up to five years
Secondary outcome [14] 0 0
Sarcopenia
Assessment method [14] 0 0
The composite outcome measure "Sarcopenia" is defined by the following three criteria: 1) low muscle strength (hand grip strength), 2) low muscle quantity (calf circumference and 3) low physical performance (gait speed). Criterion (1) identifies probable sarcopenia, additional documentation of criterion (2) confirms sarcopenia diagnosis, and if all criteria (1), (2) and (3) are met, sarcopenia is considered severe.
Timepoint [14] 0 0
Up to five years
Secondary outcome [15] 0 0
Calf circumference
Assessment method [15] 0 0
Calf circumference is measured in a standardized position and documented in centimeter.
Timepoint [15] 0 0
Up to five years
Secondary outcome [16] 0 0
Arm circumference
Assessment method [16] 0 0
Arm circumference is measured in a standardized position and documented in centimeter.
Timepoint [16] 0 0
Up to five years
Secondary outcome [17] 0 0
Adherence to Mediterranean diet (MD)
Assessment method [17] 0 0
Adherence to Mediterranean diet (MD) is measured with a German Mediscore, could range from 0 to 9, with higher scores (6-9) indicating greater MD adherence.
Timepoint [17] 0 0
Up to five years
Secondary outcome [18] 0 0
Nutrition in the hospital
Assessment method [18] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Timepoint [18] 0 0
Up to five years
Secondary outcome [19] 0 0
Physical activity
Assessment method [19] 0 0
Physical activity is evaluated by interviewing the Patient.
Timepoint [19] 0 0
At the beginning of the observation
Secondary outcome [20] 0 0
Surgical risk
Assessment method [20] 0 0
Surgical risk will be described by type and length of surgery and perioperative cardiac risk estimation as described in Anästh Intensivmed 2017; 58:349-364.
Timepoint [20] 0 0
Participants will be followed up during surgery, an estimated duration of 1 hour
Secondary outcome [21] 0 0
Anaesthesiological Risk 1
Assessment method [21] 0 0
Anaesthesiological risk will be described by American Society of Anesthesiologists Classification (ASA Class)
Timepoint [21] 0 0
At the beginning of the observation
Secondary outcome [22] 0 0
Anaesthesiological Risk 2
Assessment method [22] 0 0
Anaesthesiological risk will be measured by length of anesthesia
Timepoint [22] 0 0
Participants will be followed up during surgery, an estimated duration of 1 hour
Secondary outcome [23] 0 0
Anaesthesiological Risk 3
Assessment method [23] 0 0
Anaesthesiological risk will be measured by type of anaesthesia
Timepoint [23] 0 0
Participants will be followed up during surgery, an estimated duration of 1 hour
Secondary outcome [24] 0 0
Intraoperative depth of anaesthesia
Assessment method [24] 0 0
Intraoperative depth of sedation will be monitored with changes in the pattern and power spectrum of EEG-raw data measured with the Masimo SedLine® brain function monitoring for Root®, Narcotrend®, BIS™ and additionally quantified by indices \[e.g. PSI or BIS-index\] and burst suppression ratio.
Timepoint [24] 0 0
Participants will be followed up during surgery, an estimated duration of 1 hour
Secondary outcome [25] 0 0
Depth of sedation on the Intensive Care Unit
Assessment method [25] 0 0
Sedation is measured by Richmond Agitation Sedation Scale.
Timepoint [25] 0 0
Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Secondary outcome [26] 0 0
Sedation on the peripheral ward
Assessment method [26] 0 0
Sedation is measured by Richmond Agitation Sedation Scale.
Timepoint [26] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [27] 0 0
Agitation on the peripheral ward
Assessment method [27] 0 0
Agitation describes a clinical state in which the patient may be impulsive and attempt to get out of bed, to wander, and to fall (which may lead to further injury or death) and attempt to remove IV lines, tubes, or catheters.
Timepoint [27] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [28] 0 0
Incidence of postoperative delirium
Assessment method [28] 0 0
Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V), CAM/CAM-ICU, Nu-DESC and Chart Review.
Timepoint [28] 0 0
Up to 5 days
Secondary outcome [29] 0 0
Severity of postoperative delirium
Assessment method [29] 0 0
Postoperative delirium rate, defined according to Confusion assessment method - severity(CAM-S); Delirium Rating Scale Revised (DSR-R-98), Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC).
Timepoint [29] 0 0
Up to 5 days
Secondary outcome [30] 0 0
Duration of Delirium
Assessment method [30] 0 0
Duration of postoperative delirium, defined according to medical evaluation, measured in days
Timepoint [30] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [31] 0 0
Pain scale for patients able of pain self-assessment
Assessment method [31] 0 0
Pain during hospital stay will be measured with the Numeric Rating Scale (NRS-V).
Timepoint [31] 0 0
Up to hospital discharge, an expected average of 5 days
Secondary outcome [32] 0 0
Pain scales for patients unable of pain self-assessment
Assessment method [32] 0 0
For patients unable of pain self-assessment (e.g. ventilated patients, patients in delirious state or patients with stroke affecting language skills) observer-rated pain scales will be applied: Behavioural Pain Scale (BPS for ventilated) and BPS-NI (for non-ventilated) patients, Critical-Care Pain Observation Tool (CPOT) during hospital stay.
Timepoint [32] 0 0
Up to hospital discharge, an expected average of 5 days
Secondary outcome [33] 0 0
Intensive care unit length of stay
Assessment method [33] 0 0
Intensive care unit length of stay describes every day spent in an ICU bed.
Timepoint [33] 0 0
Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Secondary outcome [34] 0 0
Hospital length of stay
Assessment method [34] 0 0
Hospital length of stay describes every day spent in an hospital.
Timepoint [34] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [35] 0 0
Perioperative Anxiety
Assessment method [35] 0 0
Perioperative anxiety will be measured with APAIS preoperatively and the Faces Anxiety Scale (FAS) and during hospital stay.
Timepoint [35] 0 0
Up to 5 days
Secondary outcome [36] 0 0
Perception of stress
Assessment method [36] 0 0
Stress is measured by Perceived Stress Questionnaire 20
Timepoint [36] 0 0
Up to 5 days
Secondary outcome [37] 0 0
Stress level
Assessment method [37] 0 0
Stress level is measured by stress thermometer
Timepoint [37] 0 0
Up to 5 days
Secondary outcome [38] 0 0
Generalized anxiety
Assessment method [38] 0 0
Anxiety will be measured with the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Timepoint [38] 0 0
Up to 5 days
Secondary outcome [39] 0 0
Depression
Assessment method [39] 0 0
Depression is measured by PHQ-8. Scores represent:0-5 = mild, 6-10 = moderate, 11-15 = moderately severe, 16-20 = severe depression
Timepoint [39] 0 0
Up to 5 years
Secondary outcome [40] 0 0
Quality of sleep
Assessment method [40] 0 0
Quality of sleep is measured by the Insomnia Severity Index.
Timepoint [40] 0 0
Up to 5 years
Secondary outcome [41] 0 0
Routine laboratory
Assessment method [41] 0 0
Timepoint [41] 0 0
Up to hospital discharge, an expected average of 7 days
Secondary outcome [42] 0 0
Organ dysfunctions
Assessment method [42] 0 0
Organ dysfunctions are evaluated according to the Clavien-Dindo classification of surgical complications
Timepoint [42] 0 0
Up to hospital discharge, an expected average of 7 days
Secondary outcome [43] 0 0
Subjective/By proxy assessment of cognitive impairment
Assessment method [43] 0 0
Timepoint [43] 0 0
Up to five years
Secondary outcome [44] 0 0
Medication
Assessment method [44] 0 0
Prescribed regular drug intake from baseline at all follow ups including perioperative application of drugs, infusions and transfusions will be evaluated.
Timepoint [44] 0 0
Up to 5 years
Secondary outcome [45] 0 0
Quality of life
Assessment method [45] 0 0
Quality of life will be measured with the EQ-5D-5L
Timepoint [45] 0 0
Up to 5 years
Secondary outcome [46] 0 0
Level of dependency
Assessment method [46] 0 0
Level of dependency will be measured with with ADL/IADL, single items concerning patients' living situation and the BSSS-17 (Berlin Social Support Scales).
Timepoint [46] 0 0
Up to 5 years
Secondary outcome [47] 0 0
Plausibility check variables
Assessment method [47] 0 0
Variables affecting performance of cognitive testings
Timepoint [47] 0 0
Up to 5 years
Secondary outcome [48] 0 0
Re-admission
Assessment method [48] 0 0
Hospital readmission is an episode when a patient who had been discharged from a hospital is admitted again within a specified time interval.
Timepoint [48] 0 0
Up to 5 years
Secondary outcome [49] 0 0
Revison surgery
Assessment method [49] 0 0
Surgery performed to replace or compensate for a failed implant or to correct undesirable sequelae of previous surgery.
Timepoint [49] 0 0
Up to 5 years
Secondary outcome [50] 0 0
Outpatient treatment
Assessment method [50] 0 0
Treatment outside of the hospital in an associated facility for diagnosis or treatment.
Timepoint [50] 0 0
Up to 5 years
Secondary outcome [51] 0 0
Mortality
Assessment method [51] 0 0
The number of deaths in a given period.
Timepoint [51] 0 0
Up to 5 years
Secondary outcome [52] 0 0
Dementia
Assessment method [52] 0 0
Dementia reported as clinical diagnosis based on DSM-5 criteria for major NCD either through neuropsychological evaluation at a memory clinic or as a research diagnosis based on neuropsychological test values (CANTAB/MOCA), cognitive concern (MMQ/IQCODE) and functionality (ADL/IADL).
Timepoint [52] 0 0
Up to 5 years
Secondary outcome [53] 0 0
Motivational incongruence
Assessment method [53] 0 0
The incongruence questionnaire (Der Inkongruenzfragebogen)
Timepoint [53] 0 0
Up to five years
Secondary outcome [54] 0 0
Leisure behavior
Assessment method [54] 0 0
Questionnaire on frequency of cognitively stimulating leisure activities
Timepoint [54] 0 0
Up to five years
Secondary outcome [55] 0 0
Demographic variables
Assessment method [55] 0 0
Timepoint [55] 0 0
Up to five years
Secondary outcome [56] 0 0
Living conditions
Assessment method [56] 0 0
Timepoint [56] 0 0
Up to five years
Secondary outcome [57] 0 0
Postoperative electroencephalography (EEG) spectral analysis with band power
Assessment method [57] 0 0
Spectral analysis with band power are measured by EEG at third postoperative day and delirium dependent until postoperative day 7.
Timepoint [57] 0 0
Up to seven days
Secondary outcome [58] 0 0
Evaluation of pain
Assessment method [58] 0 0
Pain is measured with dolosys paintracker
Timepoint [58] 0 0
Up to three months
Secondary outcome [59] 0 0
Loneliness
Assessment method [59] 0 0
Loneliness is measured with the UCLA-Loneliness-Scale (3 items)
Timepoint [59] 0 0
Up to five years
Secondary outcome [60] 0 0
Social support
Assessment method [60] 0 0
Social support is measured with the Berliner Social-Support Skalen BSSS-17
Timepoint [60] 0 0
Up to five years
Secondary outcome [61] 0 0
Living situation
Assessment method [61] 0 0
Living situation is measured with te question: How do you live?
Timepoint [61] 0 0
Up to five years

Eligibility
Key inclusion criteria
* Surgical patients at Campus Virchow- Klinikum and Campus Charité Mitte
* Aged = 70 years
* Informed consent
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Manifest dementia
* Lack of willingness to store and disseminate pseudonymized disease data as part of the clinical trial
* Lack of readiness to participate in the follow-up examinations and contact to make an appointment
* Placement in an institute under judicial or official orders (according to German drug Law §40 (1) 4)
* Persons without a permanent residence or other circumstances that call into question the availability by telephone or post for postoperative examination
* Employees of the respective study centers
* illiteracy
* Patients with a neuropsychiatric condition that limits the performance of neurocognitive testing
* Patients with hearing and / or vision problems that limit the performance of neuro-cognitive testing
* Simultaneous participation in a prospective clinical intervention study (apart from the desired parallel participation in the anaesthesiological study Praep-Go, EA1/225/19)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2024
Sample size
Target
Accrual to date
Final
173
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Berlin

Funding & Sponsors
Primary sponsor type
Other
Name
Charite University, Berlin, Germany
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Claudia Spies, MD, Prof.
Address 0 0
Charite University, Berlin, Germany
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claudia Spies, MD, Prof.
Address 0 0
Country 0 0
Phone 0 0
+49 30 450 55 11 02
Email 0 0
claudia.spies@charite.de
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03540433